Estrogens, conjugated synthetic a - Generic Drug Details
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What are the generic sources for estrogens, conjugated synthetic a and what is the scope of patent protection?
Estrogens, conjugated synthetic a
is the generic ingredient in two branded drugs marketed by Teva Womens and Aspen, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for estrogens, conjugated synthetic a
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 25 |
Clinical Trials: | 6 |
Formulation / Manufacturing: | see details |
DailyMed Link: | estrogens, conjugated synthetic a at DailyMed |
Recent Clinical Trials for estrogens, conjugated synthetic a
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Duramed Research | Phase 4 |
The Alfred | Phase 2 |
Stanley Medical Research Institute | Phase 2 |
Paragraph IV (Patent) Challenges for ESTROGENS, CONJUGATED SYNTHETIC A
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CENESTIN | Tablets | estrogens, conjugated synthetic a | 0.3 mg, 0.45 mg and 0.9 mg | 020992 | 1 | 2009-03-19 |
CENESTIN | Tablets | estrogens, conjugated synthetic a | 0.625 mg | 020992 | 1 | 2009-03-02 |
CENESTIN | Tablets | estrogens, conjugated synthetic a | 1.25 mg | 020992 | 1 | 2008-11-03 |
US Patents and Regulatory Information for estrogens, conjugated synthetic a
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Womens | SYNTHETIC CONJUGATED ESTROGENS A | estrogens, conjugated synthetic a | CREAM;VAGINAL | 021788-001 | Nov 28, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-004 | Mar 13, 2000 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-002 | Mar 24, 1999 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-001 | Jun 21, 2002 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for estrogens, conjugated synthetic a
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-001 | Jun 21, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-005 | Feb 5, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-004 | Mar 13, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-003 | Mar 24, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |